Search Results

Avante Z Zirconia (AS) 3 Blocks consists of machinable zirconia blocks for the preparation of full ceramic crowns, onlays, and multi-unit bridges and inlay bridges (anterior and molar).

Avante Z Zirconia (AS) Blocks are partially sintered yttriastabilized zirconia blocks for use as CAD/CAM milling blanks. They are in a chalk-like state and can be milled using anv compatible CAD/CAM machine such as Sirona InLab (Sirona Dental Systems, LLC. Charlotte, NC) or KaVO Everest (Ka Vo Dental, Lake Zurich, IL). It is necessary to mill the blocks with an enlargement factor to account for the shrinkage that occurs during sintering. After the block is milled, it is sintered which causes the material to densify into a high strength ceramic suitable for dental inllays, onlays, crowns, and bridges.

The provided document is a 510(k) summary for a dental material (zirconia blocks), not a software device. Therefore, the questions related to clinical study design, algorithm performance, ground truth establishment, and expert adjudication are not applicable. The document focuses on demonstrating substantial equivalence to predicate devices based on material characteristics and intended use.

However, I can extract information relevant to the device description and intended use:

Device Description:
Avante Z Zirconia (AS)3 Blocks are partially sintered yttria-stabilized zirconia blocks designed for CAD/CAM milling. They are in a "chalk-like state" and require an enlargement factor during milling to account for shrinkage during subsequent sintering. After milling, the blocks are sintered to achieve a high-strength ceramic suitable for various dental restorations.

Intended Use:
The blocks are intended for the preparation of full ceramic crowns, onlays, and multi-unit bridges and inlay bridges (anterior and molar).

Technological Characteristics:
All components have been used in legally marketed devices, and the formulations have not been changed in a way that would adversely impact safety or efficacy.

Predicate Devices:

• IPS e.max ZirCAD by Ivoclar Vivadent AG (K051705)
• Zeno Zr Disc by Wieland Dental+Technik Gmbh&Co KG (K073108)

The 510(k) submission seeks to demonstrate substantial equivalence to these predicate devices based on the material's composition, processing, and intended use for dental restorations. The "acceptance criteria" for a material device like this would typically involve adherence to recognized material standards (e.g., ISO standards for dental ceramics) and physical/mechanical property testing (e.g., flexural strength, fracture toughness, biocompatibility). However, the provided document does not detail these specific criteria or the studies performed to meet them. It primarily states that the formulations have not changed in a way that adversely impacts safety or efficacy, implying that existing data or established properties from the predicate devices are considered relevant.

Ask a specific question about this device

Avante® Z is an all-ceramic dental restoration system used by a trained dental technician in a dental laboratory to create crowns (anterior and posterior), inlays, onlays, and veneers, with or without Zirconium Oxide (ZrO2) cores.

Avante® Z is an all-ceramic dental restoration system

This document is a 510(k) clearance letter from the FDA for a dental restoration system. It does not contain any information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Therefore, I cannot fulfill your request based on the provided text. The document primarily discusses the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices, but it does not detail the technical studies or performance metrics used to reach that conclusion.

Ask a specific question about this device